What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions like redness, swelling, or pain. Structured diabetes management programs, like those studied in the DM Discharge Toolkit trial, aim to mitigate these side effects by offering education on proper insulin use, dietary management, and blood glucose monitoring.

What prior FDA approvals exist?

For the treatment of Type 1 Diabetes, the FDA has approved various insulin therapies, including rapid-acting, long-acting, and premixed insulin formulations. These treatments are essential for managing blood glucose levels. Additionally, continuous glucose monitoring (CGM) systems have been approved to help patients self-monitor their blood glucose levels effectively. While the DM Discharge Toolkit focuses on structured guidance and resources for post-discharge management, these FDA-approved treatments provide the necessary tools for ongoing diabetes management.

What other types of research exist?

Promising alternatives to the DM Discharge Toolkit for Type 1 Diabetes patients include: 1) Hybrid Closed-Loop (HCL) insulin delivery systems, which offer automated insulin delivery based on continuous glucose monitoring, improving glycemic control and quality of life. 2) The PRIDE Toolkit, which provides culturally sensitive and literacy-appropriate diabetes education materials, supporting self-management post-discharge. 3) Digital self-management tools like MyDESMOND, which offer web-based education and support tailored to local contexts, enhancing accessibility and engagement.

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Diabetes Discharge Toolkit for Diabetes

N/A

Recruiting

Led By Amisha Wallia, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking patients

18 years of age and older

Must not have

Not been newly prescribed insulin

Patients with the inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14, 30 and 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new set of tools called the DM Discharge Toolkit to help patients who are new to using insulin manage their diabetes after leaving the hospital. The toolkit includes educational materials and practical resources to make it easier for these patients to take care of themselves at home.

Who is the study for?

This trial is for adults over 18 who have recently been prescribed insulin at hospital discharge, expected to live more than 90 days, and speak English. It's not suitable for those without a new insulin prescription, without a diabetes diagnosis, non-English speakers, or anyone unable to consent.

What is being tested?

The study is testing the 'DM Discharge Toolkit' designed to help patients manage their new insulin treatment after leaving the hospital. Participants are randomly chosen to receive this toolkit to see if it improves their care post-discharge.

What are the potential side effects?

Since this trial involves educational material rather than medication, there are no direct medical side effects. However, participants may experience stress or confusion if the information is overwhelming or unclear.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

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I am 18 years old or older.

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I need to start insulin when I leave the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not started taking insulin recently.

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I am unable to understand and give consent for treatment.

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I have not been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14, 30 and 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14, 30 and 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14, 30 and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean glucose levels

Secondary study objectives

Diabetes Distress Scale

Diabetes Symptoms Questionnaire

Glycemic variability

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DM Discharge ToolkitExperimental Treatment1 Intervention

Up to 60 participants will be recruited for the intervention group. Participants will receive the current standard of care DM education for insulin at Northwestern Memorial Hospital and the adjunctive education with the DM Discharge Toolkit.

Group II: Current Standard of Care Discharge DM TrainingActive Control1 Intervention

Up to 60 participants will be recruited for the control group. Participants will receive the current standard of care DM education for insulin use during current discharge care processes at Northwestern Memorial Hospital.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Type 1 Diabetes is insulin therapy, which involves the administration of exogenous insulin to manage blood glucose levels. Insulin works by facilitating the uptake of glucose into cells, thereby reducing blood glucose concentrations. This is crucial for Type 1 Diabetes patients, whose bodies cannot produce insulin due to autoimmune destruction of pancreatic beta cells. Structured guidance and resources, such as those provided in the DM Discharge Toolkit, are essential for helping patients manage their insulin therapy effectively post-discharge. These tools can improve adherence to treatment, optimize glycemic control, and reduce the risk of complications.

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).An Evidence Map for Interventions Addressing Transition from Pediatric to Adult Care: A Systematic Review of Systematic Reviews.The role of theories in interventions targeting preteens with Type 1 diabetes: A critical literature review.